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Ev3, Inc. - EverCross 0.035 OTW PTA Dilatation Catheter - Class 2 Recall

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ev3 EverCross 0.035" OTW PTA Dilatation Catheter Sterilized using Ethylene Oxide, 6mm x 120mm x 135cm, REF: AB35W06120135. ev3 EverCross 0.035" OTW PTA Dilatation Catheter Sterilized using Ethylene Oxide, 6mm x 40mm x, 80cm REF: AB35W06040080. The EverCross Peripheral Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semnicompliant inflatable balloon and an atraumatic, tapered tip to aid in crossing tight stenoses. The distal catheter, proximal to the balloon, is covered with a hydrophilic coating. The catheter manifold includes two lumens. The lumen marked "THRU" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis.

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